Building Toolboxes through Cross-Functional Partnerships

In the arena of pharmaceutical outsourcing, when speaking of partnerships, the discussion typically focuses on the relationship between a pharmaceutical/biopharmaceutical company as the sponsor company and a contract-service provider.

As pharmaceutical companies contend with increased cost pressure and the need to accelerate development timelines, CMOs/CDMOs play a vital role. The author examines the alliance strategies of contract services providers as a means to build their development and manufacturing capabilities and facilitate more efficient projectmanagement and technology transfer in the outsourced relationship.

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In the arena of pharmaceutical outsourcing, when speaking of partnerships, the discussion typically focuses on the relationship between a pharmaceutical/biopharmaceutical company as the sponsor company and a contract services provider. The emphasis is on the expectations between customer and supplier and the capabilities offered by the contract services provider to the sponsor company and the ways in which the project may be most effectively managed to meet specified deliverables. And while these partnerships remain the key focus of pharmaceutical outsourcing, partnerships among contract services providers, ingredient suppliers, and academia also are becoming a part of the outsourcing paradigm as companies seek to combine capabilities, services, and products to deliver a more integrated and efficient solution to a sponsor company.

Formulation development andfinished-product manufacturing

In 2012, several CDMOs and CMOs formed partnerships as a means to expand their offerings. For example, Catalent Pharma Solutions and the CDMO Bend Research partnered to provide integrated solutions for pharmaceutical companies seeking to develop and manufacture specialized multiparticulate oral controlled-release products. The companies offer combined expertise in formulation development, and Catalent provides further capabilities in analytical and chemistry, manufacturing and control (CMC) development, solid-state optimization, and clinical and commercial manufacturing. As part of their agreement, Catalent and Bend Research are developing joint operations and technology-transfer protocols. The partnership is geared toward complex, multiparticulate controlled-release products, which traditionally have presented a high scale-up risk when they are transferred to commercial manufacturing sites. The companies are aligning their scientific expertise and processes to ensure that developments are undertaken using quality-by-design principles (QbD). Bend also brings laboratory-scale modeling expertise that complements Catalent's expertise in formulation development and manufacture of controlled-release compounds. Catalent's Winchester, Kentucky facility is a commercial facility for multiparticulate products.

Earlier in 2012, Catalent Pharma Solutions and BASF formed a broad collaboration and open alliance to provide solutions to overcome bioavailability challenges of new molecular entities with solubility or permeability challenges (i.e., Biopharmaceutics Classification System Class II and IV compounds). The alliance combines the expertise of both companies to provide feasibility studies across multiple technologies, solid-state chemistry, consulting and training, formulation services, excipients, and optimal dose-form development from scale-up to commercial supply. One specific application for addressing solubility issues is the use of hot-melt extrusion (HME). BASF has a portfolio of solubilizers and excipients for HME, including its Soluplus excipient, and Catalent offers HME technologies (OptiMelt). Catalent has made recent investment in its OptiMelt HME and fluid-bed laboratory- pilot-, and commercial-scale equipment at its Schorndorf, Germany, facility as well as in training and method development at its facility in Somerset, New Jersey.

On the clinical side, Catalent and the CRO PAREXEL formed an alliance in October 2012 to provide a fully integrated, end-to-end clinical-trial-material supply-chain solution. This solution is intended to streamline the clinical supply process and reduce development timelines while improving service quality. In the alliance, PAREXEL brings clinical-trial-management services and global clinical logistics capabilities, and Catalent brings manufacturing, packaging, and labeling solutions.

To build cross-functional expertise, Catalent Pharma Solutions also launched the Catalent Applied Drug Delivery Institute to promote innovation, knowledge-sharing, and collaboration between industry leaders, academic experts, customers, and regulators to enhance understanding of available, emerging, and future drug-delivery technologies. As part of its mission, the Catalent Applied Drug Delivery Institute, which was launched in 2012, will serve as a link between industry and academia by providing guidance, counsel, and resources on major issues pertaining to drug development, drug delivery, and formulation. The institute will develop programs that facilitate mutually beneficial collaborations, increase communication, and shed light on regulatory issues affecting drug developers and researchers. It also will pursue a multitiered approach of seed funding, strategic counsel, and educational programs to advance the adoption of emerging technologies.

Other companies also are pursuing collaborations. In October 2012, Bend Research and Dow Chemical formed an exclusive collaboration to provide science-based spray-dried dispersion (SDD) solutions and select new polymers for poorly soluble oral drugs. Under the agreement, Dow and Bend Research will work together to provide fully characterized polymers supported by QbD principles as well as tailor materials to meet the performance needs of specific drugs. In addition, the two companies will develop and commercialize new materials for SDDs that address technology gaps in manufacturability and delivery to provide greater drug-product utility and therapeutic performance. Specifically, Dow will provide the excipients hypromellose and hypromellose acetate succinate as well as cellulosic and noncellulosic polymers.

The collaboration combines Dow's capabilities in materials design, high-throughput screening, and pilot-plant and commercial scale-up operations with Bend Research's SDD screening, formulation, scale-up, and technology-transfer capabilities. Dow is supporting the collaboration with several technologies, including high-throughput synthesis with API/polymer screening, laboratory-scale product development, and structure/property optimization as well as a cGMP market-development plant capable of supporting clinical development.

In January 2013, Xceleron, a provider of bioanalytical accelerator mass spectrometry (AMS) services for early drug development, partnered with Crystal Pharmatech, a China-based solid-state research CRO, to offer drug developers early bioavailability data for producing optimized solid-state forms and formulations. The partnership seeks to apply AMS technology and related expertise to address pharmacokinetic uncertainty by providing early clinical and solid-state information to provide better information earlier in drug development about a drug candidate's later-stage readiness. Xceleron applies human microdose and microtracer techniques using ultra-sensitive AMS to investigate the pharmacokinetics and metabolism of developmental drugs in Phase 0, Phase I, and Phase II/III clinical trials.